Cell-free DNA testing company Natera has introduced its Prospera transplant assessment test for lung transplant recipients.
Results from a prospective trial presented at the Chest 2021 virtual conference showed that the donor-derived cell-free DNA transplant test distinguished antibody-mediated and acute cellular rejection from stable patents with a negative predictive value of 97.3%, sensitivity of 89.1%, and an area under the curve (AUC) of 0.91, according to the vendor. In addition, the test was able to distinguish organ injury -- including acute rejection, chronic rejection, and infection -- from stable patients with an AUC of 0.76.
The firm is now commencing LAMBDA 001, a randomized controlled trial to demonstrate that Prospera surveillance is noninferior to transbronchial biopsy. In addition, another observational registry study -- LAMBDA 002 -- will assess Prospera performance for detection of chronic lung allograft dysfunction (CLAD).
Natera noted that the test has not received U.S. Food and Drug Administration (FDA) clearance.
